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December, 2021
Venue & Pricing TBA

December, 2021
Venue & Pricing TBA

Garner Efficiencies in Regulatory and Reimbursement Processes in a COVID Era

The Original Forum for Life Sciences Providing Exclusive Access to FDA/CMS Regulators to Examine Shifting Regulatory and Reimbursement Policy

Who Should Attend

You will benefit from attending this event if you are from a bio/pharma or medical device/diagnostic company with responsibilities or involvement in the following areas:

  • Regulatory Affairs
  • Government Affairs/Relations
  • Health Economics
  • Public Policy & Strategy
  • Payment and Healthcare
  • Quality
  • Patient Advocacy
  • Medicaid
  • Medicare
  • Market Access
  • R&D
  • Drug Safety
  • Rare Disease
  • Compliance
  • Gene Therapy

This conference will also benefit consultants and software providers that provide services to life science companies.

What to Expect

Garner the Latest Regulatory Updates

  • Discuss FDA and CMS perspectives on the impact of the pandemic on regulatory approval and reimbursement processes — Which efficiency and process shifts are here to stay?
  • Explore trends in decentralization and digital enablement of clinical trials — Identify next steps to achieve diversity in clinical trials
  • Advance cross-center (CBER/CDER) approaches to incorporate patient engagement in regulatory decision-making
  • Consider next steps to realize the full potential of RWE in drug development

Examine the Latest Updates to Reimbursement Policy

  • Understand the current state of value-based reimbursement models in the midst of the pandemic and the impact on the future of value-based care
  • Examine reimbursement status of new technologies and advanced therapies under new payment models
  • Review updates on Medicare coverage and access — Discuss CMS advancements in expanding telehealth benefits and the focus on improving plan incentives to align with what patients value

Political Landscape Shifts and Market Trends that Impact Drug Development

  • Assess the impact of the 2020 election on drug pricing reform
  • 21st Century Cures Act 2.0 — Consider the impact on drug development and patient access
  • Address challenges and opportunities in cell and gene therapy development
  • Evaluate the future for the drug development supply chain — What are the potential capabilities and pros/cons of domestic manufacturing?

Connect and Network with Key Decision-Makers at the 2021 FDA/CMS Summit

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